Liver Injury by Statins in Patients With History of Hepatitis B Virus Infection

Overview

The purpose of this study is to investigate the incidence of liver injury by statins in coronary heart disease (CHD) patients with history of hepatitis B virus (HBV) infection.

Full Title of Study: “Liver Injury by Statins in Coronary Heart Disease (CHD) Patients With History of Hepatitis B Virus (HBV) Infection”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: December 2020

Interventions

• Other: HBV infection history
  • HBV infection history or HBV carriers

Arms, Groups and Cohorts

• all the antigen and antibody of HBV are negative
  • Hepatitis B Virus surface antigen (HBsAg), Hepatitis B Virus surface antibody (HBsAb), Hepatitis B Virus e antigen (HBeAg), Hepatitis B Virus e antibody (HBeAb), Hepatitis B Virus core antibody (HBcAb) are all negative.
• HBV infection history
  • One or more of HBsAb,HBeAb, HBcAb are positive, while HBsAg and HBeAg are negative. If only HBsAb is positive, the history of HBV vaccination need to be excluded.
• HBV carriers
  • One or two of HBsAg and HBeAg are positive, accompanied by any HBV antibody is positive or not.

Clinical Trial Outcome Measures

Primary Measures

• changes of alanine transaminase (ALT, U/L)
  • Time Frame: one month, three months, six months
  • The peak increases of ALT from baseline to follow-up
• number of participants with alanine transaminase (ALT) increasing over 3 folds of upper limit normally (ULN)
  • Time Frame: one month, three months, six months

Secondary Measures

• number of participants with alanine transaminase (ALT) increasing over the ULN
  • Time Frame: one month, three months, six months

Participating in This Clinical Trial

Inclusion Criteria

• patients with CHD receive long-term statin treatment Exclusion Criteria:

• ALT is over ULN at baseline – infection of Hepatitis A Virus, Hepatitis C Virus or Hepatitis E Virus – triglyceride is over 4.5 mmol/L – decompensated liver cirrhosis (Child B or C) – active stage of HBV – infection of Burkitt's lymphoma virus or cytomegalovirus, or other acute infectious disease – congestive heart failure – malignant tumor – autoimmune disease – receive other potential hepatotoxicity drugs such as immunosuppressant, antituberculotic and non-steroid anti-inflammatory drug.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • The First Affiliated Hospital with Nanjing Medical University
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Zhijian Yang, Doctor, Study Chair, First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
• Overall Contact(s)
  • Zhijian Yang, Doctor, +83 13809030208, zhijianyangnj@njmu.edu.cn

References

Bellosta S, Paoletti R, Corsini A. Safety of statins: focus on clinical pharmacokinetics and drug interactions. Circulation. 2004 Jun 15;109(23 Suppl 1):III50-7. doi: 10.1161/01.CIR.0000131519.15067.1f.

Ekstedt M, Franzen LE, Mathiesen UL, Holmqvist M, Bodemar G, Kechagias S. Statins in non-alcoholic fatty liver disease and chronically elevated liver enzymes: a histopathological follow-up study. J Hepatol. 2007 Jul;47(1):135-41. doi: 10.1016/j.jhep.2007.02.013. Epub 2007 Mar 8.

Segarra-Newnham M, Parra D, Martin-Cooper EM. Effectiveness and hepatotoxicity of statins in men seropositive for hepatitis C virus. Pharmacotherapy. 2007 Jun;27(6):845-51. doi: 10.1592/phco.27.6.845.

Balmer ML, Dufour JF. Treatment of hypercholesterolemia in patients with primary biliary cirrhosis might be more beneficial than indicated. Swiss Med Wkly. 2008 Jul 26;138(29-30):415-9. doi: 10.4414/smw.2008.12311.

Cohen DE, Anania FA, Chalasani N; National Lipid Association Statin Safety Task Force Liver Expert Panel. An assessment of statin safety by hepatologists. Am J Cardiol. 2006 Apr 17;97(8A):77C-81C. doi: 10.1016/j.amjcard.2005.12.014. Epub 2006 Feb 3.

Watkins PB, Seeff LB. Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology. 2006 Mar;43(3):618-31. doi: 10.1002/hep.21095.

Lu J, Zhou Y, Lin X, Jiang Y, Tian R, Zhang Y, Wu J, Zhang F, Zhang Y, Wang Y, Bi S. General epidemiological parameters of viral hepatitis A, B, C, and E in six regions of China: a cross-sectional study in 2007. PLoS One. 2009 Dec 24;4(12):e8467. doi: 10.1371/journal.pone.0008467.

Citations Reporting on Results

Zhang Q, Yang Z. Can statins be used safely in coronary heart disease patients of hepatitis B virus carriers? Int J Cardiol. 2011 Jan 21;146(2):291. doi: 10.1016/j.ijcard.2010.10.087. Epub 2010 Dec 3. No abstract available.